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510(k) K210989

Device
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System
Applicant
Brainlab AG
510(k) number
K210989
Product code
HAW  
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-12
Date received
2021-04-02
Regulation
882.4560
Classification name
Neurological Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chiara Cunico
Address
Olof-Palme-Str.9 Munich DE 81829 81829

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HAW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253663Zeta Navigation SystemZeta Surgical, Inc.2026-05-01
K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.2026-03-26
K231897NeuroAlign softwareMedivis, Inc.2025-10-21
K251317SOLOPASS 2.0 SystemIntravent Medical Partners2025-09-05
K250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.2025-09-04
K250505EZ-FIDUCIALSPhasor Health, LLC2025-07-09
K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.2025-05-23
K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav2025-02-05
K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITTBrainlab AG2025-01-28
K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.2025-01-24
K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.2025-01-17
K242480FLASH EVD System (10-0002)7D Surgical ULC2024-12-27
K242351Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.2024-10-04
K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc.2024-04-26
K233155ClearPointer Optical Navigation WandClearPoint Neuro, Inc.2024-01-12

Legacy Summary#

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FDA Review#

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